Sevelamer carbonate dry suspension for oral administration

The technology of sevelamer carbonate and dry suspension, which is applied in the field of pharmaceutical preparations, can solve the problems of poor compressibility, troublesome medication, large tablet volume, etc., and achieve the effects of improving compliance and reducing the number of times of taking

Active Publication Date: 2017-11-24
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The dosage form of commercially available sevelamer carbonate is tablet and dry suspension at present, and these two kinds of dosage forms have advantages and disadvantages respectively, and tablet volume is less, and is convenient to carry, has incomparable advantage as long-term medication, but because this The drug dosage of the product is relatively large (2.4~4.8g / day), and the commercially available tablet specification is 800mg or 400mg. Because the raw material of sevelamer carbonate has poor compressibility, the high proportion of excipients causes the tablet volume to be relatively large. Patients with dysphagia have great troubles with medication; the dry suspension can solve the disadvantages of dysphagia after being dispersed in water
[0010] CN104800165A provides Sevelamer Carbonate Dry Suspension, which has uniform particle distribution, good stability, large distribution area in the gastrointestinal tract, fast absorption, high bioavailability, fast drug onset, and better efficacy than Sevelamer Carbonate Premix, but the suspension is a fast-acting drug, which has poor compliance for patients who take it for a long time

Method used

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  • Sevelamer carbonate dry suspension for oral administration
  • Sevelamer carbonate dry suspension for oral administration
  • Sevelamer carbonate dry suspension for oral administration

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Sevelamer carbonate 180g, hydroxypropyl methylcellulose 210g, microcrystalline cellulose 150g, gum arabic 30g, magnesium stearate 24g, sucrose 3g and titanium dioxide 3g.

[0029] Pass sevelamer carbonate, hydroxypropyl methylcellulose, microcrystalline cellulose, gum arabic and magnesium stearate through 80 mesh sieves respectively, and sucrose and titanium dioxide pass through 60 mesh sieves respectively; Ram, suspending agent and filler, add water and mix evenly to prepare soft material; weigh the binder, glidant, flavoring agent and coloring agent of the formula and add them to the above soft material to make carbonic acid Sevelamer wet granules, dry sub-packaging to obtain sevelamer carbonate dry suspension.

Embodiment 2

[0031] Sevelamer carbonate 300g, hydroxypropyl methylcellulose 150g, microcrystalline cellulose 90g, gum arabic 42g, magnesium stearate 12g, sucrose 5g and titanium dioxide 5g.

[0032] Pass sevelamer carbonate, hydroxypropyl methylcellulose, microcrystalline cellulose, gum arabic and magnesium stearate through 80 mesh sieves respectively, and sucrose and titanium dioxide pass through 60 mesh sieves respectively; Ram, suspending agent and filler, add water and mix evenly to prepare soft material; weigh the binder, glidant, flavoring agent and coloring agent of the formula and add them to the above soft material to make carbonic acid Sevelamer wet granules, dry sub-packaging to obtain sevelamer carbonate dry suspension.

Embodiment 3

[0034] Sevelamer carbonate 240g, hydroxypropyl methylcellulose 180g, microcrystalline cellulose 120g, gum arabic 30g, magnesium stearate 27g, sucrose 1.5g and titanium dioxide 1.5g.

[0035] Pass sevelamer carbonate, hydroxypropyl methylcellulose, microcrystalline cellulose, gum arabic and magnesium stearate through 80 mesh sieves respectively, and sucrose and titanium dioxide pass through 60 mesh sieves respectively; Ram, suspending agent and filler, add water and mix evenly to prepare soft material; weigh the binder, glidant, flavoring agent and coloring agent of the formula and add them to the above soft material to make carbonic acid Sevelamer wet granules, dry sub-packaging to obtain sevelamer carbonate dry suspension.

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Abstract

The invention relates to a sevelamer carbonate dry suspension. The sevelamer carbonate dry suspension comprises 35-55% of a suspending aid, 15-25% of a filler, 5-10% of a binder, 2-5% of dextrin, 2-5% of magnesium stearate, 0.1-1% of sucrose and 0.1-1% of titanium dioxide. The sevelamer carbonate dry suspension can improve action time of sevelamer carbonate in the human body and improve drug compliance.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a sevelamer carbonate composition and a preparation method thereof. Background technique [0002] Hyperphosphatemia is common in patients with end-stage renal disease, and hyperphosphatemia can cause hyperparathyroidism and osteodystrophy. Recent studies have found that hyperphosphatemia can still induce soft tissue and vascular calcification, which is an important factor for the increased mortality and cardiovascular disease in patients with end-stage renal disease. Therefore, effective control of serum phosphorus levels has become an important measure to reduce the mortality and incidence of cardiovascular diseases in patients with end-stage renal disease. At present, the treatment of hyperphosphatemia mainly includes dietary phosphorus restriction, dialysis treatment, application of phosphorus binders and removal of parathyroid glands when necessary. First of all, th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/785A61K47/38A61K47/02A61K47/26A61P13/12A61P3/12
Inventor 陈阳生王明刚刘晓霞孙桂玉臧云龙
Owner CP PHARMA QINGDAO CO LTD
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